Top

Tag: biotechnology


Industry, Pharma

BMS and Janssen’s antithrombotic granted FDA fast track designation

May 26, 2023

Via: PMLiVE

The designations for the investigational oral factor XIa inhibitor cover all three indication-seeking studies within the phase 3 Librexia development programme: ischaemic stroke, acute coronary syndrome and atrial fibrillation. According to the companies, the programme aims to evaluate whether milvexian […]


FDA, Regulations

FDA Approves AbbVie’s Bispecific Antibody for Treating Lymphoma

May 25, 2023

Via: Biopharm International

AbbVie announced on May 19, 2023 that FDA has approved EPKINLY (epcoritamab-bysp), a T-cell engaging bispecific antibody for treating relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL). The bispecific is particularly indicated for treating adult patients with R/R DLBCL, […]


Industry, Vaccines

FDA Grants Full Approval to Paxlovid to Treat COVID-19

May 25, 2023

Via: Drugs.com

Americans with COVID-19 have been taking Paxlovid since it was approved under emergency use in late 2021. Today, the U.S. Food and Drug Administration granted full approval to the drug. This approval will allow drugmaker Pfizer to sell the medication […]


Manufacturing, Research and Development

TriLink BioTechnologies to Expand Manufacturing Capabilities

May 24, 2023

Via: Biopharm International

TriLink BioTechnologies announced the expansion of its messenger RNA (mRNA) manufacturing capabilities on May 24, 2023. The new construction of the current good manufacturing practice (CGMP)-grade facility will help the company with its mission to advance the field as more […]


Industry, Pharma

FDA approves new antibiotic for hospital-acquired pneumonia

May 24, 2023

Via: Biopharma Dive

Acinetobacter baumannii are a common cause of pneumonia in hospitals, and infections can be life-threatening. Innoviva’s treatment consists of a drug, sulbactam, that’s similarly structured as the antibiotic penicillin, along with another compound, durlobactam, that helps protect it from degradation. […]


FDA, Regulations

FDA delays decision on Duchenne gene therapy and considers narrower approval

May 24, 2023

Via: Biopharma Dive

The Food and Drug Administration has delayed its review of a closely watched gene therapy for Duchenne muscular dystrophy by one month, taking more time to consider whether approval should be initially limited to children who are most likely to […]


Industry, Vaccines

Pfizer’s maternal RSV vaccine candidate backed by FDA advisory committee

May 23, 2023

Via: PMLiVE

The Vaccines and Related Biological Products advisory committee (VRBPAC) voted unanimously that the available data supported the efficacy of RSVpreF in helping to protect against the complications of RSV in infants from birth to six months of age. The committee […]


FDA, Regulations

Blueprint wins key FDA approval for rare disease drug

May 23, 2023

Via: Biopharma Dive

The launch of Ayvakit in indolent systemic mastocytosis, or ISM, is being closely watched by investors and analysts. Blueprint brought two drugs to market in recent years — Ayvakit and the cancer drug Gavreto — and since expanded use of […]


Clinical Trials, Research and Development

How the digital front door benefits clinical trial patients, clinicians and sponsors

May 22, 2023

Via: Biopharma Dive

Opening the digital front door to clinical trials means creating a great user experience for patients, clinicians and ultimately sites and sponsors. As anyone in healthcare knows all too well, it has historically been much easier said than done. However, […]


Cell and Gene Therapy, Industry

FDA approves Krystal gene therapy for rare wound disorder

May 22, 2023

Via: Biopharma Dive

Dystrophic epidermolysis bullosa is one of four main types of the disorder. Depending on the inheritance pattern, the condition can be severe and disabling, causing blisters anywhere on the skin from minor trauma and friction. The form Vyjuvek is cleared […]


FDA, Regulations

FDA Issues Guidance on Pediatric Drugs

May 18, 2023

Via: Biopharm International

While the world may have marched on from the halcyon days of the mid-20th century where the United States was the undisputed center of the global economy, the country’s continual impact should not be understated. Particularly as it concerns the […]


Industry, Vaccines

FDA Panel Backs First RSV Vaccine Given in Pregnancy

May 18, 2023

Via: Drugs.com

The first vaccine designed to protect infants against respiratory syncytial virus (RSV) by vaccinating their mothers during pregnancy has been backed by a panel of advisers to the U.S. Food and Drug Administration. On Thursday the independent committee of experts […]


Cell and Gene Therapy, Industry

Siren emerges from stealth with plans to marry gene therapy to cancer immunotherapy

May 17, 2023

Via: Biopharma Dive

Two and a half years ago, Nicole Paulk’s coworkers told her to start a company. The gene therapy researcher and then University of California, San Francisco assistant professor had just showed them data from mice studies testing a new kind […]


News

Gilead picks former Roche executive to run cell therapy unit Kite

May 17, 2023

Via: Biopharma Dive

Gilead Sciences on Tuesday named former Roche executive Cindy Perettie as the next head of its cell therapy business Kite Pharma, moving quickly to fill the vacancy left by Christi Shaw, who stepped down from the role at the end […]


FDA, Regulations

FDA staff unsure NASH drug’s ‘modest’ benefits outweigh safety risks

May 17, 2023

Via: Biopharma Dive

Food and Drug Administration scientists reviewing what could become the first medicine for the fatty liver disease NASH are skeptical the treatment’s safety risks outweigh its “modest” benefits, according to documents made public Wednesday. The documents were posted online ahead […]


Cell and Gene Therapy, Industry

CATTI Opens Cell and Gene Therapy Training Center of Excellence

May 16, 2023

Via: Contract Pharma

The Canadian Advanced Therapies Training Institute (CATTI) Inc. launched its first in-person training site at the University of Guelph through a partnership with OmniaBio Inc., CCRM and the university. The training program, to begin in summer 2023, will cater to […]


Cell and Gene Therapy, Industry

Biotech startup Ray raises $100M for vision-restoring gene therapies

May 16, 2023

Via: Biopharma Dive

Diseases of the eye have been a popular target for gene therapy development, due in part to the potential for efficient delivery via injection as well as the lower risk of dangerous immune responses. Luxturna, the first gene therapy for […]


Cell and Gene Therapy, Industry

Life Biosciences, Forge Biologics Partner for Manufacturing to Advance Gene Therapies

May 15, 2023

Via: Biopharm International

Life Biosciences, a biotechnology company, and Forge Biologics, a genetic medicines manufacturing organization, announced on May 8, 2023 that they are in a manufacturing partnership to help advance Life Bio’s partial epigenetic reprogramming platform to further address aging-related diseases, according […]


Clinical Trials, Research and Development

GSK’s five-in-one meningococcal vaccine candidate shows promise in phase 3 trial

May 15, 2023

Via: PMLiVE

Preliminary results for the MenABCWY candidate were presented by the company at the European Society for Paediatric Infectious Diseases congress in Lisbon, Portugal. Invasive meningococcal disease (IMD) is an uncommon but serious illness that can cause life-threatening complications or even […]


Industry, Pharma

FDA Panel Recommends Approval of First Nasal Spray, Neffy, to Combat Severe Allergy Attacks

May 12, 2023

Via: Drugs.com

Outside advisors for the U.S. Food and Drug Administration voted Thursday to recommend approval of Neffy, the first epinephrine nasal spray for severe allergic reactions. Although most of the Pulmonary-Allergy Drugs Advisory Committee members supported the spray for adults (16:6) […]